|6.1.2 the organization shall plan:
Actions to address these risks & opportunities
Integrate and implement actions in QMS
Evaluate the effectiveness of actions
Actions taken = proportionate to the potential impact on conformity of products and services
| Shall consider issues from the context of the organization and interested parties and determine risks and opportunities that need to be addressed to:
Ensure the QMS can achieve intended results
Enhance desirable effects
Prevent or reduce undesired effects
| Org chart, job descriptions or procedure is typical
Reporting may be done in management review
Regular management meetings cover metrics
Change management procedure?
| Is there a Management Rep designated
Where are these items defined? (No documentation explicitly required)
Who monitors the effectiveness of processes?
How is the integrity of the QMS maintained when there are changes?